Check-valve for tracheotomy tubes

ABSTRACT

A removable check-valve for installation on the external portion of a tracheotomy tube including a housing containing a freefloating, flat type disc for opening and closing the tracheotomy tube during the breathing cycle regardless of the body position of the user. An auxiliary port may be provided on the housing for supplying supplemental oxygen continuously to the user without direct loss of oxygen to the atmosphere.

United States Patent 1191 Birch et a1' 1 1 Aug. 6, 1974 I 1 CHECK-VALVE FOR TRACHEOTOMY 3,137,299 6/1964 Tabor 128/351 TUBES [76] Inventors: Arthur I. Birch, 6178 S. Windcmerc a y Examinerwchanning L. Pace Way, Littleton, Colo, 80102; Attorney, Agent, or FirmRichard D. Law Darrell E. Brown, 4994 E. Gcddes Ct., Littleton, Colo. 80122 57 AB TRACT [22] Filed: Jan. 18, 1973 l S A removable check-valve for installation on'thc exter- [ZH Appl' 32473l nal portion of a tracheotomy tube including a housing containing a free-floating, flat type disc for opening [52] US. Cl. 128/351 and closing the tracheotomy tube during the breathing [51] Int. Cl A61m 16/00 cycle regardless of the body position of the user. An [58] Field of Search 128/351; 3/1.3 auxiliary port may be provided on the housing for supplying supplemental oxygen continuously to the user [56] References Cited without direct loss of oxygen to the atmosphere. UNITED STATES PATENTS 2,039.142 4/1973 Brehm 128/351 13 Clams 7 Drawmg Flgures CHECK-VALVE FOR TRACHEOTOMY TUBES This invention is directed to a valve to facilitate speech by a person after the surgical installation of a tracheotomy tube.

Under certain pathological abnormalities, such as bilateral paralysis of the vocal chords, a breathing impediment is created in the throat of an individual. Under these conditions, the individual is unable to inhale sufficient air to supply adequate oxygen to maintain normal health or activity. This condition necessitates the forming of an auxiliary air passage to again restore free breathing. A generally routine surgical procedure called a tracheotomy is performed which creates a stoma at the base of the neck. A tracheotomy tube, constructed of material inert to human tissue, is inserted through the stoma into the trachea to maintain the auxiliary passageway open for unimpeded inhalation of air to the lungs.

Several major disadvantages are created by the open tracheotomy tube. Foremost among these disadvantages is the individuals inability to speak. In order to speak, the exhalation of air through the tracheotomy tube must be prevented, thus forcing air to flow through the vocal chords. This is usually accomplished by placing a finger over the open external end of the tracheotomy tube. This technique is undesirable, however, in that a hand must be held to the throat which is not only inconvenient and embarrassing but is, in some cases such as an extremely arthritic person, impossible. An additional disadvantage is the inability of the patient to expel secretions from the lungs by coughing through the mouth. Without a means for quickly closing the tracheotomy tube, secretions are expelled out through the tube when coughing. This creates an unpleasant and messy accumulation of mucus, etc. around the tracheotomy tube.

Several devices have been proposed to remedy this problem by mounting a one-way valve or check-valve on the exterior end of the tracheotomy tube to automatically close the tube during exhalation and force the air upward through the vocal chords and mouth. These devices sometimes diminish the value of the tracheotomy tube by creating an impediment to the free intake of air either due to their nature of construction or the accumulation of secretions from the trachea caused by the expulsion of air normally necessary to close the valve.

The ideal valve for this type of usage is one in which only a minute pressure differential is required to close the valve, eliminating or reducing return air flow and the introduction of secretions into the valve cavity. The valve should also be capable of operating regardless of the patients body position. The present invention is directed to a valve which demonstrates these characteriscorroding, inert to human tissue and capable of being cleaned and sterilized as desired.

It is, therefore, an object of the present invention to provide a positive acting tracheotomy tube checkvalve which is easily operated by a persons normal breathmg.

It is a further object of the present invention to pro vide a tracheotomy closure device which can operate in any position and still provide a positive seal automatically during exhalation.

It is another object of the present invention to provide a closure device which is easily attached or detached from a tracheotomy tube. Also, a device is provided which requires only one operating part of simple construction which provides reliable operation.

It is another object of the present invention to provide a tracheotomy closure device which is small in size and easily hidden under normal neckwear and outer garments.

Another object of the present invention is to provide a device which can be used to continuously supply oxygen to the user, such as an encephalitic patient, without the direct loss of the oxygen to the atmosphere.

Other objects and features of this invention will appear in the following description and appended claims, reference being made to the accompanying drawings forming a part of the specification, wherein like reference charactersdesignate corresponding parts in the several views.

FIG. 1 is a cut-away side elevational view of an installed tracheotomy tube and an attached closure device according to the present invention,

FIG. 2 is a perspective view of a tracheotomy tube closure device according to the present invention showing a stop pin provided on the front wall;

FIG. 3 is a side elevational view showing the relationship of the various parts in phantom lines;

FIG. 4 is a front elevational view of the device;

FIG. 5 shows a cross sectional view of the device taken along lines 55 shown in FIG. 4;

FIG. 6 is a-rear elevational view of the closure device showing one form of attachment means; and

FIG. 7 is a side elevational view of a modified form of the. closure device, showing a different type of attachment for a tracheotomy tube.

More specifically, as illustrated in FIG. 1, a tracheotomy tube valve 10 according to the present invention is shown. The valve is arranged to be mounted on the exterior end 11 of a tracheotomy .tube 12 which has been inserted surgically through the patients throat 13 into the trachea or windpipe 14. The exterior end 11 of the tracheotomy tube can be terminated in any form desired. For the sake of illustration, a flange I5 is shown on the exterior end 11 of the tube.

The mounting device for the valve 10, described hereinbelow, is arranged for mounting the valve directly to the tracheotomy tube flange 15. It is obvious that the mounting device provided for the valve 10 can be of any design which is compatible for coupling of the valve to the tracheotomy tube in use. The primary consideration is that the mounting should fit the tube securely and provide a seal to prevent airflow between the valve and tube.

The tracheotomy tube valve 10 includes an outer housing, FIGS. 2-4, which defines a valve cavity 27, formed by the front wall 16, bottom wall 20, inner rear wall 21 and sidewalls l8, 19. An air inlet opening or aperture 28 is formed at a generally central location in the bottom wall 20. An air outlet opening or aperture 29 is provided in the upper portion of the inner rear wall 21. This opening is positioned along the center line of the back wall 21 between the sidewalls 18, 19.

As shown in the embodiment of FIG. 5, a rear outer wall 22 suspended from a closed top wall 17 and extensions of the sidewalls 18, 19 is provided. The rear outer wall 22 is positioned at an angle with respect to the inner wall 21 forming a slightly wedge-shaped cavity 23 having an open wider end 24 at the bottom of the hous- A centrally located slot 25, FIG. 6, provided in the outer rear wall 22, has an open end 26 extending from the lower end 24 of cavity 23. The width of the slot 25 is sized to fit the outside dimension of the tracheotomy tube 12. The width of the tapered cavity 23, as seen in FIG. 5, is arranged to fit and slightly compress the flange as the housing 10 is slid downward over the flanged end of the tube 12, holding it tightly on wall 21 over the opening 29.

It is also emphasized that any type of mounting arrangement can be provided for attaching the inner rear wall 21 and the outlet opening 29 to the end of the tracheotomy tube 12. If a direct tube coupling with the inner rear wall 21 is provided, it is obvious that the outer rear wall 22, top wall 17 and extension portions of the sidewalls l8, 19 which form the wedge cavity 23, can be omitted. Also, a tapered tube may be extended from the wall 21 for insertion into certain types of tracheotomy tubes.

The tapered tube is shown in FIG. 7. In this embodiment a tapered tube 40 is secured to wall 21a, the wall 22 of the device of FIGS. 2-6 having been removed for forming this embodiment. The closure device, therefore, includes front wall 16a, with a stop device 32a, extending downwardly and outwardly from the top of wall 16a. Side walls, similar to walls 18 and 19 of the device of FIG. I, extend between the front and rear wall leaving a generally triangular cross-section cavity therein. A bottom wall a is mounted at a slight angle downwardly from the wall 21a, and it is provided with a beveled opening 28a. A valve element 30a is mounted in the cavity, and its upper corner cut-outs 37a fit loosely the arcuate guides 36a. The tapered tube is arranged to fit in a tube, with the taper providing means for a friction fit in such a tube.

A generally rectangular, flat valve element or disc 30, having a rounded front edge 31, is arranged freefloating within the valve cavity 27. For the purpose of this specification, the term free-floating, as used herein, describes the arrangement where the valve element 30 is disposed for pivotal movement within the housing, but is not connected by any mechanical means, such as a hinge, to the housing itself. The rounded edge 31 of the element 30 aids in pivotal movement of the element with a minimum of drag or friction. An arrangement such as this is highly desirable in this type of device, since any mechanical connection produces frictional drag which would increase the effort required to move an actuate the element 30.

The valve element 30, positioned within the cavity 27, pivots around the edge 31 with the rear edge 38 movable upwardly towards the air outlet opening 29. Notches 37 are provided at the corners of the rear edge 38. Guide elements or plates 34, 35 are attached to the inside surfaces of the sidewalls 19 and 18, respectively.

An arcuate cutout 36 is provided in each of the guide elements 34 and 35 having a radius which is approximately equal to the length of the side of the valve element 30. The guide elements 34, 35 are intended to have a thickness which is slightly less than the width of each notch 37 and are mounted to the sidewalls so that the notches 37 will easily clear and move along the arcuate cutout portions 36 of the guide elements. In this arrangement, the forward edge 31 of the valve element 30 is held adjacent the line of intersection between the bottom wall 20 and the front wall -16. The rear edge 38 of the disc 30 is guided in its pivotal movement by the notches 37 and the arcuate guide elements 34, 35. The element 30 is positioned against the bottom wall 20 in closed position.

The edge of the inlet opening 28, as shown in FIG. 3, is beveled so as to reduce air turbulence and resulting noise. When the valve element 30 is positioned against the bottom wall 20, a seal is provided to prevent return air flow through the tracheotomy device. As the user inhales through the tracheotomy tube 12 a reduced pressure or vacuum is created in the cavity 27. Atmospheric pressure forces the valve element 30 upward as shown in FIG. 5, so that air flow can freely pass from the air inlet opening 28 through the outlet opening 29 into the tracheotomy tube 12.

r A stop device 32 extends inwardly from the inside surface of the front wall 16 to limit the upward pivotal movement of the valve element 30. In the present embodiment, the stop device 32 is shown as a rivet or pin inserted through a hole 33 provided in the front wall 16 and cemented in place. It is to be understood that any type of stop device may be used, i.e. a dimple in wall 16. The rivet type pin is suggested herein since it is easy to position and mount and reduces the likelihood of breakage and possible inhalation into the users lungs.

The stop device 32 performs two functions. The first is that the valve element 30 is prevented from lying flat against the front wall 16 which could cause the element to stick to the wall if moisture is present in the valve cavity 27. The second function is to limit the angular opening of the element 30 with respect to the outlet opening 29 so that quick valve action may be obtained and to restrict the opening of the valve element to a position below the center line of the opening 29. The phantom line position as seen in FIG. 5 shows the valve in the open position. In order for the valve to work rapidly in any position, return air flow through the outlet 29 is utilized to close the valve element 30. In this way, sufficient pressure is created behind the element to force it to the closed position. With the opening of the element restricted to no more than one-half of the area of the outlet opening 29, sufficient air flow is permitted to impinge against the front wall 16 to create this pressure. Although the desired angular opening of the element 30 is determined by the relative position of the air outlet opening 29, it has been found in the embodiment shown in FIG. 5 that an angle of approximately 30 to 45 provides a free flow of air, yet permits rapid and positive closing of the element 30. In the normal upright position, the valve element 30 drops into the closed position by force of gravity the instant inhalation ceases.

With the valve housing arrangement as described herein, any problem of secretion accumulation within the cavity 27 is eliminated. Secretions are prevented means for carrying secretions into the valve are also eliminated.

An oxygen tube connection 39 can be provided through the sidewall opening 40 of the housing (see FIG. 4). The opening through the tube connection passes directly into the valve cavity 27. With the oxygen inlet opening 39, provided in the side of the housing 10, oxygen can be directed continuously into the valve cavity 27 where it will pass directly through the tracheotomy tube 12 and into the lungs of the user. The additional oxygen will be mixed with the incoming air but will not be lost directly to the atmosphere on exhalation because of the closed valve element 30.

The device described herein can be made from any non-corrosive material desired. A material which is ideal for this type of structure would be any of the lightweight plastics, such as methacrylates, polyethylenes, polypropylenes, various vinyl polymers and copolymers and many such similar plastics. With the use of these materials, the valve unit can be easily cleaned, as required, and even sterilized. If desired, the housing can be formed from transparent, clear plastic materials, so that the user can easily see the cleanliness of the valve cavity. In addition, the actuation of the valve element can be observed to ascertain if any difficulty or restriction in the valve element movement is evident.

While a tracheotomy valve closure device has been shown and described in detail, it is obvious that this invention is not to be considered as being limited to the exact form disclosed and that changes and details in construction may be made therein, within the scope of the invention, without departing from the spirit thereof.

Having thus set forth and disclosed the nature of this invention, what is claimed is:

1. A tracheotomy valve device comprising:

a. an enclosed housing means having first and second flat walls arranged generally perpendicular to each other and intersecting each other along a common edge, said housing means includes means for mounting the housing on the exterior end of a tracheotomy tube suitably implanted in the throat of a user;

b. an air inlet means provided in said first wall of said housing to allow air to pass into said housing;

c. an air outlet means provided in said second wall of said housing and communicating with said mounting means whereby air can pass through the outlet means into said tracheotomy tube; and

d. a closure means having an unattached valve element positioned within said housing, said valve element having a base edge disposed adjacent to an edge of said first wall opposite said second wall, said valve being arranged to move about said base edge from a closed position adjacent said first wall covering the air inlet means to prevent the expulsion of air from the housing through the air inlet means during exhalation by the user to an open position allowing air to pass unimpeded through the housing from the inlet means directly to the outlet means and the tracheotomy tube during inhalation.

2. A valve device as defined in claim 1, wherein: said air inlet means includes a centrally located aperture provided in the first wall of said housing; and

said valve element is a flat, rectangular disc having opposing side edges and an outer edge opposite to said base edge, said valve element being sized to cover said aperture when in the closed position.

3. A valve device as defined in claim 2, wherein:

the housing includes a guide means mounted within housing for guiding the disc in its movement between the closed and open positions to prevent jamming or sticking of the disc.

4. A valve device as defined in claim 3, wherein:

said guide means includes a pair of flat members mounted along opposite said walls of the housing which are positioned adjacent to the opposite side edges of the disc;

said flat members having arcuate cut-outs to correspond to the length of the side edges of the disc whereby the disc is free to move with respect to the housing, but is held with the base edge adjacent to the edge of the first wall of the housing.

5. A valve device as defined in claim 1, wherein:

said housing means includes a stop means which is arranged to contact the valve element and limit the movement of said element in the open position.

6. A valve device as defined in claim 1, wherein:

said housing includes guide means provided within the housing for guiding the valve element as it moves so as to provide free and unrestricted movement.

7. A valve device as defined in claim 1, wherein:

said mounting means includes a double second wall formed in said housing means, said air outlet means being centrally disposed in the inner second wall, said second walls being arranged at a slight acute angle with respect to each other thereby forming a wedge-shaped chamber open at its widest end, the outermost second wall having an open slot extending inwardly from the edge of the wall adjacent the open side of the chamber whereby the valve assembly can be mounted on a flange provided on the exterior end of the tracheotomy tube by sliding the outer second wall over the tube with the flange being positioned in the chamber to form a seal with the air outlet means.

8. A valve device as defined in claim 1, wherein:

said mounting means includes a cylindrical duct means attached to the outer surface of said housing second wall and extending outwardly from said outlet means, said cut means being arranged to be inserted into the exterior end of the tracheotomy tube to form an air seal with said tube.

9. A valve device as defined in claim 1, wherein:

said valve element opens in a direction away from said second wall and said housing means includes a stop means for restricting said element to an open position not exceeding the center line of the air outlet means whereby reverse airflow during exhalation will pass behind the closure means causing it to move to the closed position.

10. A valve device as defined in claim 1, wherein:

said housing means and said closure means are formed from a transparent plastic material so that operation of the closure means and cleanliness of the housing means can be observed.

12. A tracheotomy valve device comprising:

a. housing means having at least a first wall and a second wall, said housing means further including means for mounting the housing on the exterior end of a tracheotomy tube suitably implanted in the throat of a user;

b. air inlet means provided in said first wall of said housing means;

0. air outlet means provided in said second wall of said housing means and communicating with said mounting means whereby air brought into the housing through said inlet means can pass through the outlet means and into the tracheotomy tube;

d. said first wall of said housing means intersects said second wall and is sloped downwardly from said second wall; and

e. closure means having an unattached valve element mounted within said housing for movement from a closed position adjacent said first wall covering the air inlet means preventing the expulsion of air from the air inlet means during exhalation by the user to an open position allowing passage of air from the inlet means through the outlet means and the tracheotomy tube duringinhalation.

13. A tracheotomy valve device comprising:

a. housing means having means for mounting the housing at the exterior end of a tracheotomy tube,

said housing being arranged so that the cross sectional shape of the housing is in the form of a right triangle;

b. air inlet means provided in an inlet wall of said housing'means and an air outlet means provided in an adjacent outlet wall positioned at right angles to the inlet wall, said outlet means communicating with said mounting means whereby air brought into the housing can pass through the outlet means and into the tracheotomy tube;v

. closure means having an unattached valve element positioned within said housing means for movement from a closed position adjacent said inlet wall covering said air inlet means and preventing the expulsion of air through the air inlet means during exhalation by a user to an open position allowing passage of air from the inlet means through the outlet means and into the tracheotomy tube during inhalation; and

(1. said valve element being arranged to open so as to means. 

1. A tracheotomy valve device comprising: a. an enclosed housing means having first and second flat walls arranged generally perpendicular to each other and intersecting each other along a common edge, said housing means includes means for mounting the housing on the exterior end of a tracheotomy tube suitably implanted in the throat of a user; b. an air inlet means provided in said first wall of said housing to allow air to pass into said housing; c. an air outlet means provided in said second wall of said housing and communicating with said mounting means whereby air can pass through the outlet means into said tracheotomy tube; and d. a closure means having an unattached valve element positioned within said housing, said valve element having a base edge disposed adjacent to an edge of said first wall opposite said second wall, said valve being arranged to move about said base edge from a closed position adjacent said first wall covering the air inlet means to prevent the expulsion of air from the housing through the air inlet means during exhalation by the user to an open position allowing air to pass unimpeded through the housing from the inlet means directly to the outlet means and the tracheotomy tube during inhalation.
 2. A valve device as defined in claim 1, wherein: said air inlet means includes a centrally located aperture provided in the first wall of said housing; and said valve element is a flat, rectangular disc having opposing side edges and an outer edge opposite to said base edge, said valve element being sized to cover said aperture when in the closed position.
 3. A valve device as defined in claim 2, wherein: the housing includes a guide means mounted within housing for guiding the disc in its movement between the closed and open positions to prevent jamming or sticking of the disc.
 4. A valve device as defined in claim 3, wherein: said guide means includes a pair of flat members mounted along opposite said walls of the housing which are positioned adjacent to the opposite side edges of the disc; said flat members having arcuate cut-outs to correspond to the length of the side edges of the disc whereby the disc is free to move with respect to the housing, but is held with the base edge adjacent to the edge of the first wall of the housing.
 5. A valve device as defined in claim 1, wherein: said housing means includes a stop means which is arranged to contact the valve element and limit the movement of said element in the open position.
 6. A valve device as defined in claim 1, wherein: said housing includes guide means provided within the housing for guiding the valve element as it moves so as to provide free and unrestricted movement.
 7. A valve device as defined in claim 1, wherein: said mounting means includes a double second wall formed in said housing means, said air outlet means being centrally disposed in the inner second wall, said second walls being arranged at a slight acute angle with respect to each other thereby forming a wedge-shaped chamber open at its widest end, the outermost second wall having an open slot extending inwardly from the edge of the wall adjacent the open side of the chamber whereby the valve assembly can be mounted on a flange provided on the exterior end of the tracheotomy tube by sliding the outer second wall over the tube with the flange being positioned in the chamber to form a seal with the air outlet means.
 8. A valve device as defined in claim 1, wherein: said mounting means includes a cylindrical duct means attached to the outer surface of said housing second wall and extending outwardly from said outlet means, said cut means being arranged to be inserted into the exterior end of the tracheotomy tube to form an air seal with said tube.
 9. A valve device as defined in claim 1, wherein: said valve element opens in a direction away from said second wall and said housing means includes a stop means for restricting said element to an open position not exceeding the center line of the air outlet means whereby reverse airflow during exhalation will pass behind the closure means causing it to move to the closed position.
 10. A valve device as defined in claim 1, wherein: said housing means and said closure means are formed from a transparent plastic material so that operation of the closure means and cleanliness of the housing means can be observed.
 11. A valve device as defined in claim 1, wherein: said housing includes an auxiliary connecting means mounted so that a gas can be continuously introduced into the housing for flow into the tracheotomy tube regardless of the valve element position.
 12. A tracheotomy valve device comprising: a. housing means having at least a first wall and a second wall, said housing means further including means for mounting the housing on the exterior end of a tracheotomy tube suitably implanted in the throat of a user; b. air inlet means provided in said first wall of said housing means; c. air outlet means provided in said second wall of said housing means and communicating with said mounting means whereby air brought into the housing through said inlet means can pass through the outlet means and into the tracheotomy tube; d. said first wall of said housing means intersects said second wall and is sloped downwardly from said second wall; and e. closure means having an unattached valve element mounted within said housing for movement from a closed position adjacent said first wall covering the air inlet means preventing the expulsion of air from the air inlet means during exhalation by the user to an open position allowing passage of air from the inlet means through the outlet means and the tracheotomy tube during inhalation.
 13. A tracheotomy valve device comprising: a. housing means having means for mounting the housing at the exterior end of a tracheotomy tube, said housing being arranged so that the cross sectional shape of the housing is in the form of a right triangle; b. air inlet means provided in an inlet wall of said housing means and an air outlet means provided in an adjacent outlet wall positioned at right angles to the inlet wall, said outlet means communicating with said mounting means whereby air brought into the housing can pass through the outlet means and into the tracheotomy tube; c. closure means having an unattached valve element positioned within said housing means for movement from a closed position adjacent said inlet wall covering said air inlet means and preventing the expulsion of air through the air inlet means during exhalation by a user to an open position allowing passage of air from the inlet means through the outlet means and into the tracheotomy tube during inhalation; and d. said valve element being arranged to open so as to move away from and out of the path of the air passing from the inlet means to the outlet means during inhalation, said housing means including a stop means whereby said valve element is restricted to an opening whereby an edge of the valve element does not exceed the centerline of the outlet means whereby the reverse airflow during exhalation will impinge on said housing means and pass behind the closure means causing it to move to the closed position irrespective of the orientation of the housing means. 